An observational study between two drugs that prevent activity of the immune system in patients after liver transplant

Not Applicable

• Conditions: Health Condition 1: null- Liver Transplant

• Registration Number: CTRI/2013/08/003938
• Lead Sponsor: Medanta The Medicity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1 Patient of either gender who are aged 18 to 70 years

2 Patient is a primary living donor liver transplant recipient

3 Female patients of child bearing potential must have a negative urine or serum pregnancy test before transplant

4 Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures

5 Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen

Exclusion Criteria

1 Patient has previously received or is receiving an organ transplant other than a liver,Multi-organ transplant patients.

2 Patient has received a liver transplant from a deceased donor, an ABO incompatible donor liver

3 Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)

4 Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.

5 Patients with thrombocytopenia (30,000/mm3), and/or leukocytopenia (2,000/mm3) with an absolute neutrophil count of 1,000/mm3 and/or hemoglobin 7.0 g/dL prior to enrollment.

6 Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives

7 Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant

8 Patient has a known hypersensitivity to tacrolimus or cyclosporine, enteric-coated mycophenolate sodium or corticosteroids

9 Patient is pregnant or lactating

10 Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves

Study & Design

• Study Type: Observational
• Study Design: Not specified